The O3 Regional Oximetry platform has been expanded to allow monitoring of infant and neonatal patients <10 kg

> O3 may help clinicians monitor cerebral oxygenation in situations in which peripheral pulse oximetry alone may not be fully indicative of the oxygen in the brain

> O3 integrates with Masimo SET® pulse oximetry on Root®, providing clinicians with expanded visibility of a patient’s oxygenation status

> 3% ARMS1 trending accuracy specification on neonatal patients

> With its reduced size and flexible design, the O3 neonatal sensor easily conforms to and allows for ergonomic application on small foreheads

O3® Regional Oximetry Available for Adult, Paediatric, Infant and Neonatal Applications

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asimo. A

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Masimo InternationalTel: +41 32 720 1111info-international@masimo.com

Masimo U.S.Tel: 1 877 4 Masimo info-america@masimo.com

Application Site . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Forehead Wavelengths . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 Neonatal rSO2 Sensor Accuracy (ARMS)2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . <10kg

Trending Regional Oxygen Saturation (rSO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3% Paediatric rSO2 Sensor Accuracy (ARMS)2 . . . . . . . . . . . . . . . . . . . . . . . . . . . ≥5 kg and <40 kg

Absolute Regional Oxygen Saturation (rSO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5% Trending Regional Oxygen Saturation (rSO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3%

Adult rSO2 Sensor Accuracy (ARMS)2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ≥40 kg Absolute Regional Oxygen Saturation (rSO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4% Trending Regional Oxygen Saturation (rSO2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3%

PHYSICAL CHARACTERISTICS

Length (including cable) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 .1 ft (3 .7 m) Width . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 .8 in (4 .6 cm) Thickness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .0.6 in (1.5 cm) Weight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 .1 oz max (200 g max)

O3 Display

O3 MOC-9 Module Specifications

For professional use . See instructions for use for full prescribing information, including indications, contraindications, warnings, and precautions .

The Root patient monitoring and connectivity hub offers plug-and-play monitoring with Masimo Open Connect® (MOC-9®) modules.*

ENVIRONMENTAL

Operational Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 to 104° F (0 to 40° C) Storage Temperature . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .-40 to 158° F (-40 to 70° C) Operating and Storage Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . .10 to 95%, non-condensing Altitude . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Up to 12,000 ft (3700 m)

O3 Sensor SpecificationsENVIRONMENTAL

Operating Temperature at Ambient Humidity . . . . . . . . . . . . . . . . . . . . 41 to 104° F (5 to 40° C) Storage Temperature at Ambient Humidity . . . . . . . . . . . . . . . . . . . -40 to 140° F (-40 to 60° C) Storage Humidity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15% to 95%, 86 to 140° F (30 to 60° C)

O3 Monitoring

Apply the appropriate O3 sensors to the forehead:> Infant and Neonatal Adhesive Sensor (<10 kg) > Paediatric Adhesive Sensor (≥5 kg and <40 kg)> Adult Adhesive Sensor (≥40 kg)

Connect the O3 sensors to an O3 MOC-9 module (up to two sensors per module)

Connect the O3 MOC-9 module to one of three MOC-9 ports on Root

11 2 3

1 ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within ± ARMS of the reference measurements in a controlled study. * In countries with regulatory approval and Root devices with the correct software version.

AdultPaediatricInfant and Neonatal

The O3 System with infant and neonatal sensors is not licensed for sale in Canada .

Δbase Displays the difference between current rSO2 and user-defined baseline

rSO2 Tissue oxygen saturation

AUC Area Under the Curve index quantifies the depth and duration of patient- stay below user-defined rSO2 low alarm limit

∆SpO2 Displays the difference between SpO2 (from the Radical-7®, if applicable) and rSO2

ΔO2Hbi Displays an index representing the change in the

oxyhaemoglobin component of the rSO2 calculation

ΔcHbi Displays an index representing the sum of the ΔO2Hbi and ΔHHbi components of the

rSO2 calculation

ΔHHbi Displays an index

representing the change in the deoxyhaemoglobin

component of the rSO2 calculation